IVD Department Qualitative IgM Antibody Test for SARS-CoV-2 - Vietnam Registration 2403393ĐKLH/BYT-HTTB

1. Access SARS-CoV-2 IgM is a fluorescent bead-based immunoassay for the qualitative detection of IgM antibodies against SARS-CoV-2 in human serum, plasma and blood (anticoagulated with EDTA, citrate and heparin) on the Access Immunoassay System. When combined with clinical presentation and other laboratory tests in the laboratory, Access SARS-CoV-2 IgM supports the diagnosis of SARS-CoV-2 infection and helps identify patients with an immune response to SARS-CoV-2, indicating recent primary infection or prior infection. The result of the Access SARS-CoV-2 IgM test should not be used as the sole basis for diagnosing SARS-CoV-2 infection. 2. Access SARS-CoV-2 IgM Calibrator is used to calibrate the Access SARS-CoV-2 IgM test, the qualitative in vitro immunoassay for the detection of IgM antibodies against SARS-CoV-2 in human serum, plasma and blood (anticoagulated with heparin, EDTA and citrate), and is only intended for use on the Access Immunoassay System. 3. Access SARS-CoV-2 IgM QC is used to monitor the performance of the Access SARS-CoV-2 IgM test. Access SARS-CoV-2 IgM QC is only intended for use on the Access Immunoassay System.